DRP · Tourniquet, Automatic Rotating
Cardiovascular · 21 CFR 870.5925 · Class 2
Overview
| Product Code | DRP |
|---|---|
| Device Name | Tourniquet, Automatic Rotating |
| Regulation | 21 CFR 870.5925 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An automatic rotating tourniquet is a device that prevents blood flow in one limb at a time, which temporarily reduces the total blood volume, thereby reducing the normal workload of the heart.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.